NCT03827603 (ISRAEL) is a Phase 2 clinical trial of Ibrutinib in AIHA - Warm Autoimmune Hemolytic Anemia, sponsored by Eugene Nikitin.

Who is sponsoring NCT03827603?

NCT03827603 is sponsored by Eugene Nikitin.

What drugs are being tested in NCT03827603?

Interventions in NCT03827603: Ibrutinib.

What condition does NCT03827603 study?

NCT03827603 studies AIHA - Warm Autoimmune Hemolytic Anemia.

Is NCT03827603 still recruiting?

NCT03827603 is currently status unknown. Last updated 10 January 2020.

Last reviewed 2020-01-10 · How we verify

NCT03827603: ISRAEL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ibrutinib in Steroid Refractory Autoimmune Hemolytic Anemia

Status unknown Phase 2 Last updated 10 January 2020

What this trial tests

Phase 2 trial testing Ibrutinib in AIHA - Warm Autoimmune Hemolytic Anemia in 50 participants. Status unknown.

Timeline

21 February 2017

Primary endpoint
1 December 2019

31 March 2022

Quick facts

Lead sponsor	Eugene Nikitin
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	21 February 2017
Primary completion	1 December 2019
Estimated completion	31 March 2022
Sites	1 location across Russia

Drugs / interventions tested

Ibrutinib (ibrutinib) — full drug profile →

Conditions studied

AIHA - Warm Autoimmune Hemolytic Anemia — all drugs for AIHA - Warm Autoimmune Hemolytic Anemia →

Sponsor

Eugene Nikitin

Who can join

18 and older, any sex, with AIHA - Warm Autoimmune Hemolytic Anemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-labeled, single arm, Phase II, two staged study of combination of ibrutinib and rituximab in patients with autoimmune cytopenia and underlying CLL. In stage I (remission induction) patients will receive ibrutinib and rituximab for 6 months; in stage II (maintenance) - only ibrutinib until relapse, progression or unacceptable toxicity. A total of 50 patients will be enrolled into the trial. The results will be compared to historical control, efficacy of rituximab as monotherapy or in combination with chemotherapy in patients with AIC and underlying CLL.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Autoimmune hemolytic anemia: current knowledge and perspectives.
Michalak SS, Olewicz-Gawlik A, Rupa-Matysek J, Wolny-Rokicka E, et al · · 2020 · cited 72× · PMID 33292368 · DOI 10.1186/s12979-020-00208-7
Autoimmune Cytopenias in Chronic Lymphocytic Leukemia: Focus on Molecular Aspects.
Fattizzo B, Barcellini W. · · 2019 · cited 55× · PMID 31998632 · DOI 10.3389/fonc.2019.01435
Bruton's Kinase Inhibitors for the Treatment of Immunological Diseases: Current Status and Perspectives.
Robak E, Robak T. · · 2022 · cited 45× · PMID 35628931 · DOI 10.3390/jcm11102807
Clinical Trials of the BTK Inhibitors Ibrutinib and Acalabrutinib in Human Diseases Beyond B Cell Malignancies.
Zhu S, Jung J, Victor E, Arceo J, et al · · 2021 · cited 23× · PMID 34778053 · DOI 10.3389/fonc.2021.737943
Autoimmune Hemolytic Anemias: Challenges in Diagnosis and Therapy.
Barcellini W, Fattizzo B. · · 2024 · cited 10× · PMID 39371250 · DOI 10.1159/000540475
Rise of the planet of rare anemias: An update on emerging treatment strategies.
Fattizzo B, Motta I. · · 2022 · cited 8× · PMID 36698833 · DOI 10.3389/fmed.2022.1097426
Bruton's tyrosine kinase inhibition attenuates disease progression by reducing renal immune cell invasion in mice with hemolytic-uremic syndrome.
Kröller S, Wissuwa B, Dennhardt S, Krieg N, et al · · 2023 · cited 7× · PMID 36911665 · DOI 10.3389/fimmu.2023.1105181
The Role of Novel Agents in Treating CLL-Associated Autoimmune Hemolytic Anemia.
Noto A, Cassin R, Mattiello V, Reda G. · · 2021 · cited 7× · PMID 34065833 · DOI 10.3390/jcm10102064

Verify or expand the search:

Other trials of Ibrutinib

Trials testing the same drug.

NCT07377578 — A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cel · Phase 3 · recruiting
NCT07052695 — Mosunetuzumab for CLL MRD Clearance · Phase 1, PHASE2 · recruiting
NCT06649812 — Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggress · Phase 2 · recruiting
NCT07169565 — Ibrutinib Followed by BR (Bendamustine and Rituximab) as a Time-Limited Therapy for Waldenström Macroglobulinemia · Phase 1 · not yet recruiting
NCT06357676 — Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma, IGNITE MCL Trial · Phase 1, PHASE2 · recruiting

Other recruiting trials for AIHA - Warm Autoimmune Hemolytic Anemia

Currently open trials in the same condition.

NCT07019038 — National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03827603 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eugene Nikitin
Last refreshed: 10 January 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03827603.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing